NCT02424955

Brief Summary

The purpose of this study is to prospectively analyze the value of 3D ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 11, 2023

Completed
Last Updated

July 11, 2023

Status Verified

June 1, 2023

Enrollment Period

7.6 years

First QC Date

April 16, 2015

Results QC Date

June 19, 2023

Last Update Submit

June 19, 2023

Conditions

Liver CancerLiver TumorHepatocellular CarcinomaLiver Carcinoma

Keywords

Liver cancerHepatocellular CarcinomaLiver imagingStereotactic Ablative RadiotherapySABR

Outcome Measures

Primary Outcomes (3)

  • Changes in Blood Perfusion (Blood Volume)

    The purpose of this pilot project is to prospectively analyze the value of 3D ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.

    Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.

  • Changes in Blood Perfusion (Mean Flow Velocity)

    The purpose of this pilot project is to prospectively analyze the value of 3D ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.

    Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.

  • Changes in Blood Perfusion (Relative Blood Flow)

    The purpose of this pilot project is to prospectively analyze the value of 3D ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.

    Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.

Study Arms (1)

3D Perfusion Ultrasound

EXPERIMENTAL

undergo 3D ultrasound perfusion imaging with perflutren

Drug: perflutren lipid microspheresDiagnostic Test: 3D ultrasound

Interventions

perflutren lipid microspheresDRUG
Also known as: Definity
3D Perfusion Ultrasound
3D ultrasoundDIAGNOSTIC_TEST
3D Perfusion Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to understand and willingness to sign the written informed consent document
  • Patient with primary liver tumor or metastasis scheduled for Stereotactic Ablative Radiotherapy (SABR)
  • Patient is at least 18 years of age. No gender/race-ethnic restrictions.
  • Performance status (ECOG) between 0-3
  • History and Physical done within 4 weeks of enrollment.

You may not qualify if:

  • Patient has previously been enrolled in and completed this study.
  • Known right to left cardiac shunt, bidirectional or transient.
  • Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
  • History of hypersensitivity to the contrast agent perflutren
  • History of pulmonary hypertension
  • Patients who are pregnant or are trying to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

perflutren

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Results Point of Contact

Title
Lucas Kas Vitzthum
Organization
Stanford University
ccto-website@stanford.edu
(650) 498-6000

Study Officials

  • Daniel T. Chang

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 23, 2015

Study Start

November 18, 2014

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 11, 2023

Results First Posted

July 11, 2023

Record last verified: 2023-06

Locations

US(1)